Connective Tissue Motion Measure 2

Stromatec

Status: Completed

Conditions: Musculoskeletal Pain; Low Back Pain

Treatments: Device: StromaGlide

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01784094

2R44AT006085

Details and patient eligibility

About

This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for all subjects:

• able to stand and walk without assistance
• able to read and understand English
• able to understand and sign a consent form

Inclusion Criteria for low back pain subjects:

• history of recurrent or chronic low back pain

Inclusion criteria for no-low back pain subjects:

• no history of low back pain or other chronic pain that has limited activities of daily living or work
• numerical chronic pain index of less than 0.5

Exclusion Criteria for all subjects:

• previous severe back or lower extremity injury or surgery
• major structural spinal deformity (scoliosis, kyphosis, stenosis)
• ankylosing spondylitis or rheumatoid arthritis
• neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica))
• radicular pain
• neurological or major psychiatric disorder
• bleeding disorders
• corticosteroid or anticoagulant medication
• substance abuse
• pregnancy
• active worker's compensation or disability case
• in litigation for a low back pain problem
• acute systemic infection

Trial design

195 participants in 2 patient groups

Low back pain subjects

Description:

Subjects with chronic or recurrent low back pain

Treatment:

Device: StromaGlide

No low back pain subjects

Description:

Subjects who are generally healthy with no low back pain

Treatment:

Device: StromaGlide